Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorder
Mood Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder wh...
Detailed Description
Several treatments are available for the treatment of acute manic and mixed episodes associated with bipolar disorder. Some of these treatments although used for many years, are associated with well-k...
Eligibility Criteria
Inclusion
- Meets Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM IV) criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features)
- history of at least 1 previously documented manic or mixed episode requiring medical treatment within 3 years before the screening phase
- total score of at least 20 on the YMRS at screening and at baseline
- if taking mood stabilizers, antipsychotics, or antimanic drugs, must have discontinued that medication at least 3 days before baseline
- women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization)
- able and willing to comply with self-administration of medication, or have consistent help or support available.
Exclusion
- Meets DSM-IV criteria for rapid cycling and schizoaffective disorder
- In the opinion of the study doctor, is at significant risk for suicidal or violent behavior during the course of the study
- Has used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid (excluding codeine), hallucinogen, or any other drug that may be associated with manic symptoms as evidenced by a positive urine drug screen
- Has received benzodiazepines at doses equal to 4 mg/day of lorazepam or higher for a period of 3 months or longer immediately before the screening phase.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT00309699
Start Date
April 1 2006
End Date
November 1 2007
Last Update
June 20 2014
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
Cerritos, California, United States
2
Garden Grove, California, United States
3
Oceanside, California, United States
4
San Diego, California, United States